WHA
 

Constipation Agents - ST, NF

Indications for Prior Authorization

Amitiza (lubiprostone)
  • For diagnosis of Chronic Idiopathic Constipation (CIC)
    Indicated for the treatment of CIC in adults.

  • For diagnosis of Opioid-Induced Constipation in Adult Patients with Chronic Non-Cancer Pain
    Indicated for the treatment of opioid-induced constipation (OIC) in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

    Limitations of Use: Effectiveness of Amitiza in the treatment of opioid-induced constipation in patients taking diphenylheptane opioids (e.g., methadone) has not been established.

  • For diagnosis of Irritable Bowel Syndrome with Constipation
    Indicated for the treatment of irritable bowel syndrome with constipation in women at least 18 years old.

Linzess (linaclotide)
  • For diagnosis of Irritable Bowel Syndrome with Constipation (IBS-C)
    Indicated in adults and pediatric patients 7 years of age and older for the treatment of irritable bowel syndrome with constipation (IBS-C).

  • For diagnosis of CIC
    Indicated in adults for the treatment of CIC.

  • For diagnosis of Functional Constipation (FC)
    Indicated in pediatric patients 6 to 17 years of age for the treatment of functional constipation (FC).

Movantik (naloxegol)
  • For diagnosis of Opioid-Induced Constipation (chronic non-cancer pain, chronic pain related to prior cancer or its treatment)
    Indicated for the treatment of OIC in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

Motegrity (prucalopride)
  • For diagnosis of CIC
    Indicated for the treatment of CIC in adults.

Relistor (methylnaltrexone bromide) injection
  • For diagnosis of Opioid-Induced Constipation (advanced illness or pain caused by active cancer) [1, 2]
    Indicated for the treatment of OIC in adult patients with advanced illness or pain caused by active cancer who require opioid dosage escalation for palliative care.

  • For diagnosis of Opioid-Induced Constipation (chronic non-cancer pain, chronic pain related to prior cancer or its treatment)
    Indicated for the treatment of OIC in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

Relistor (methylnaltrexone bromide) tablet
  • For diagnosis of Opioid-Induced Constipation (chronic non-cancer pain, chronic pain related to prior cancer or its treatment)
    Indicated for the treatment of OIC in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

Symproic (naldemedine)
  • For diagnosis of Opioid-Induced Constipation (chronic non-cancer pain, chronic pain related to prior cancer or its treatment)
    Indicated for the treatment of OIC in adult patients with chronic non-cancer pain, including patients with chronic pain related to prior cancer or its treatment who do not require frequent (e.g., weekly) opioid dosage escalation.

Trulance (plecanatide)
  • For diagnosis of Chronic Idiopathic Constipation (CIC)
    Indicated in adults for the treatment of CIC.

  • For diagnosis of Irritable Bowel Syndrome With Constipation (IBS-C)
    Indicated in adults for the treatment of IBS-C.

Criteria

Brand Amitiza

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure (minimum 30 days supply), contraindication, or intolerance to one of the following generics: [A]
    • Lactulose
    • Polyethylene glycol
    AND
  • Trial and failure (minimum 30 days supply), contraindication, or intolerance to one of the following preferred brands: [B]
    • Linzess
    • Movantik
    • Symproic
Movantik, Symproic, generic prucalopride

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure (minimum 30 days supply), contraindication or intolerance to one of the following generics [A]:
    • Lactulose
    • Polyethylene glycol
Linzess

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • One of the following: [A]
    • Both of the following:
      • Patient is 16 years of age or younger
      • Trial and failure (minimum 30 days supply), contraindication or intolerance to generic lactulose
      OR
    • Both of the following:
      • Patient is 17 years of age or older
        • AND
      • Trial and failure (minimum 30 days supply, contraindication or intolerance to one of the following generics: [A]
        • Lactulose
        • Polyethylene glycol
Brand Motegrity

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure (minimum 30 days supply), contraindication, or intolerance to one of the following generics: [A]
    • Lactulose
    • Polyethylene glycol
    AND
  • Trial and failure (minimum 30 days supply), contraindication, or intolerance to Linzess
    • AND
  • Trial (minimum 30 days supply) or intolerance to generic prucalopride
Relistor injection, Relistor tablet

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure (minimum 30 days supply), contraindication, or intolerance to one of the following generics: [A]
    • Lactulose
    • Polyethylene glycol
    AND
  • Trial and failure (minimum 30 days supply), contraindication, or intolerance to one of the following preferred brands: [B]
    • Movantik
    • Symproic
    AND
  • Trial and failure (minimum 30 days supply), contraindication, or intolerance to generic lubiprostone
Trulance

Step Therapy

Length of Approval: 12 Month(s)

  • Requested drug is being used for a Food and Drug Administration (FDA)-approved indication
    • AND
  • Trial and failure (minimum 30 days supply), contraindication, or intolerance to one of the following generics: [A]
    • Lactulose
    • Polyethylene glycol
    AND
  • Trial and failure (minimum 30 days supply), contraindication, or intolerance to Linzess
    • AND
  • Trial and failure (minimum 30 days supply), contraindication, or intolerance to generic lubiprostone
Trulance

Non Formulary

Length of Approval: 3 Month(s)

  • Submission of medical records (e.g., chart notes) confirming diagnosis of one of the following:
    • irritable bowel syndrome with constipation (IBS-C)
    • chronic idiopathic constipation (CIC)
    AND
  • Submission of medical records (e.g., chart notes) confirming one of the following [C]:
    • For a diagnosis of IBS-C, both of the following:
      • Patient has recurrent symptoms of abdominal pain, occurring, on average, at least 1 day per week, over the past 3 months
        • AND
      • Abdominal pain is associated with TWO of the following:
        • Defecation
        • A change in stool pattern or frequency
        • A change in stool form or appearance
      OR
    • For a diagnosis of CIC, both of the following:
      • All of the following:
        • Constipation is not predominantly associated with recurrent abdominal pain
        • Patient does not fulfill criteria for IBS diagnosis
        • Patient does not experience loose stools without the use of laxatives
        AND
      • Both of the following:
        • Patient has experienced at least two of the following symptoms over the past 3 months:
          • Fewer than 3 defecations per week
          • Straining
          • Lumpy or hard stools
          • Sensation of incomplete evacuation
          • Sensation of anorectal obstruction
          • Manual maneuvers to facilitate defecation
          AND
        • Provider attests that these symptoms are present for at least 25% of defecations
        AND
    AND
  • Patient is 18 years of age or older
    • AND
  • Used as an adjunct to lifestyle modifications (e.g., increase intake of fibers and fluids, increase physical activity)
    • AND
  • Submission of medical records (e.g. chart notes) or paid claims confirming trial and failure (minimum 30 days supply), contraindication, or intolerance to ONE the following generics: [A]
    • Lactulose
    • Polyethylene glycol
    AND
  • Submission of medical records (e.g. chart notes) or paid claims confirming trial and failure (minimum 30 days supply), contraindication, or intolerance to both of the following:
    • Linzess
    • generic lubiprostone
    AND
  • For indication of CIC, submission of records (e.g., chart notes) or paid claims confirming trial and failure (minimum 30 days supply), contraindication, or intolerance to generic prucalopride

  • Guideline ID
    GL-741192

  • Formulary
    Premium

  • Effective date
    Nov 1, 2026

  • P&T approval date
    Aug 18, 2008

P & T Revisions

2026-10-13, 2026-08-28, 2026-03-25, 2025-12-10, 2025-09-23, 2025-03-24, 2025-02-05, 2025-01-22, 2024-04-24, 2024-03-13, 2023-10-25, 2023-07-26, 2023-07-26, 2023-03-23, 2023-01-21, 2022-03-09, 2021-09-30, 2021-05-05, 2021-03-02, 2020-03-09

  1. Relistor Prescribing Information. Salix Pharmaceuticals. Bridgewater, NJ. May 2024.
  2. Per clinical consult with gastroenterologist, February 19, 2019.
  3. Crockett SD, Greer KB, Heidelbaugh JJ, et al. American Gastroenterological Association Institute Guideline on the Medical Management of Opioid-Induced Constipation. Gastroenterology. Gastroenterology. 2019;156:218-226.
  4. Movantik Prescribing Information. AstraZeneca Pharmaceuticals LP. Wilmington, DE. April 2020.
  5. Symproic Prescribing Information. BioDelivery Sciences International Inc. Raleigh, NC. July 2025.
  6. Linzess Prescribing Information. Allergan USA, Inc. Madison, NJ. November 2025.
  7. Trulance Prescribing Information. Salix Pharmaceuticals Inc. Bridgewater, NJ. March 2024.
  8. Amitiza Prescribing Information. Takeda Pharmaceuticals America, Inc. Deerfield, IL. November 2020.
  9. Motegrity Prescribing Information. Takeda Pharmaceuticals America, Inc. Lexington, MA. July 2025.
  10. Ford AC, Moayyedi P, Chey WD, Harris LA, Lacy BE, Saito YA, Quigley EMM; ACG Task Force on Management of Irritable Bowel Syndrome. American College of Gastroenterology Monograph on Management of Irritable Bowel Syndrome. Am J Gastroenterol. 2018 Jun;113(Suppl 2):1-18.
  11. Bellini M, Gambaccini D, Usai-Satta P, De Bortoli N, Bertani L, Marchi S, Stasi C. Irritable bowel syndrome and chronic constipation: Fact and fiction. World J Gastroenterol. 2015 Oct 28;21(40):11362-70. doi: 10.3748/wjg.v21.i40.11362. PMID: 26523103; PMCID: PMC4616212. Accessed september 2026.
  12. Rome IV Criteria | The Rome Foundation. www.theromefoundation.org. Accessed September 2026.
  1. Stimulant and osmotic laxatives should be tried/failed first before patients are placed on OIC agents (ie, Relistor and Movantik). [2, 3]
  2. The 2019 American Gastroenterological Association (AGA) Guideline for Opioid-Induced Constipation (OIC) recommends traditional laxative therapy as first-line agents given their established efficacy, safety, and lower cost. If an adequate trial of laxatives does not optimally control symptoms, the AGA recommends treatment with peripherally acting mu-opioid receptor antagonist (PAMORA) drugs with higher quality evidence of efficacy, namely naldemedine and naloxegol. [2]
  3. Rome IV criteria - Comprehensive diagnostic standards for functional gastrointestinal disorders (11, 12)
  • 2026-10-13: Addition of drug specific non-form criteria for Trulance.
  • 2026-08-28: Expanded age indication for Linzess. Update to Linzess criteria to allow those under 17 yoa to bypass trial of polyethylene glycol (PEG only indicated in 17 yoa and older)
  • 2026-03-25: 2026 UM Annual Review. No criteria changes
  • 2025-12-10: Updated indication for Linzess. Added IL statute operational note.
  • 2025-09-23: GPI change for Relistor
  • 2025-03-24: 2025 UM Annual Review. No criteria changes. Background updates
  • 2025-02-05: Updated Brand Motegrity criteria to require trial of generic prucalopride
  • 2025-01-22: Added generic prucalopride to guideline
  • 2024-04-24: Operational updates - added Amitiza GPI back to guideline, missing from Amitiza criteria bucket
  • 2024-03-13: 2024 UM Annual Review. No criteria changes
  • 2023-10-25: Added t/f/c/i to generic lubiprostone requirement for Relistor and Trulance
  • 2023-07-26: Added new indication for Linzess for functional constipation
  • 2023-07-26: Removed generic lubiprostone as target from the ST
  • 2023-03-23: 2023 UM Annual Review. No criteria changes. Added minimum 30 day trial duration to trial and failure requirements. Updated references.
  • 2023-01-21: update guideline
  • 2022-03-09: 2022 UM Annual Review.
  • 2021-09-30: Attached EHB formulary to guideline, benefit coverage effective 1/1/2022. No changes to clinical criteria.
  • 2021-05-05: 2021 UM Annual Review.
  • 2021-03-02: Added new ABA for Amitiza to guideline. Named product "brand lubiprostone."
  • 2020-03-09: 2020 UM Annual Review. No changes to criteria.